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EXECUTIVE SUMMARY
Introduction
Product launch strategy case studies
The evolution of product launches
Future product launch strategies
New product planning in the pharmaceutical industry
Introduction
Summary
Introduction
The importance of launch
Declining productivity means decreasing returns
Launch performance predicts later growth
Product launch strategy case studies
Summary
Introduction
Clinical differentiation
Significant improvement in efficacy enabled Viread to penetrate the HIV market
Eylea – third to launch but with an improved dosing schedule
Humira – a prefilled syringe helped challenge the competition
Maximizing commercial efforts can optimize a launch
Aggressive marketing makes a dent in a highly competitive market
Cymbalta - identifying new unmet needs in depression
Merck’s promotional strategy led to the success of Gardasil
The evolution of product launches
Summary
Introduction
Pros and cons of being first-to-market
There is a short window to recoup the investment in new drug development
Shifting a treatment paradigm is a key strategic aim for pharmaceutical companies
Pricing and reimbursement drives the race to launch first
Innovation rather than first to market status is key to success
The upside of being a follower
Is there such a thing as a blockbuster launch anymore?
Lipitor – the most successful product of all time
Blockbuster launches are still obtainable, but in a different guise
Future product launch strategies
Summary
Introduction
Advances in medicine have left few unmet needs
Launching into a niche indication can be a fast track route to market
Specific segments provide physicians with a clear patient profile
There has been a recent rebound of launches into large therapeutic areas
Obtaining product approval is becoming more challenging
Increased scrutiny of clinical data leads to a higher percentage of rejections
Approval can come with conditions attached
Payers needs must be addressed to ensure a successful launch
A comprehensive market access strategy is key for launch
Companies must adapt their approach to payers
Growing conservatism is limiting pre-launch activity
Disease awareness programs – a matter for interpretation
Pre-launch efforts are being increasingly restricted to medical activities
New product planning in the pharmaceutical industry
Summary
Introduction
New product planning lays the foundation for a successful launch
Linking R&D and commercial strategy is essential for launch success
When to activate the NPP?
Launch preparation and launch, a period of intense activity
Marketing activities are traditionally at the heart of launch planning
The medical function has increased responsibility
Market access is fundamental in a launch plan
Market research and analysis plays an important role
Many other functions are needed to ensure a complete launch planning process
Launch readiness – will some products get the go ahead?
The importance of post-launch surveillance
Appendix
Scope
Methodology
Primary research
Secondary research
Abbreviations
Bibliography/References
Annual reports and 10-k filings
Websites
List of Tables
Table: Cost of new drug approval: analysis
Table: Top 20 drugs by global revenue, 2010
Table: Key recent launches of novel products into areas of high unmet need
Table: Suggested activities for NPP teams during clinical development
Table: Suggested activities for NPP teams during clinical development (cont’d)
Table: Medical activities plan for a new product launch: internal education activities and medical affairs objectives
List of Figures
Figure: Number of substances investigated to achieve one product launch, 2002
Figure: Examples of product lifecycles
Figure: Effects of activities to increase uptake following a poor launch
Figure: Viread global sales ($m), 2001–10
Figure: Gilead’s HIV portfolio sales ($m), 2001–10
Figure: Global sales performance for GSK and Gilead’s HIV brands ($m), 1996–2010
Figure: Comparison of the key anti-TNF inhibitors
Figure: Humira adverts placed the patient firmly at the center
Figure: Humira’s first year sales compared to initial uptake of Enbrel and Remicade
Figure: An example of Lilly advertizing creating the link between depression and pain
Figure: A shot from a Cymbalta television advertizement
Figure: Cipralex and Cymbalta global sales since launch ($m), 2002–10
Figure: Estimated Cymbalta sales for depression and pain indications
Figure: Gardasil global sales since launch ($m), 2006–10
Figure: Viagra global sales since launch ($m), 1998–2010
Figure: Expenditure on DTC and healthcare provider promotion by drug by quarter ($m), 2000–08
Figure: Number of prescriptions filled by drug by quarter, 2000–08
Figure: Global sales of ED drugs ($m), 2000–10
Figure: US market shares of statins, January 1997
Figure: Cholesterol-lowering drug physician details, US, 1997
Figure: Examples of drugs rejected by the FDA/EMA in 2011
Figure: The changing influence of stakeholders
Figure: Health economic criteria required in the EU markets
Figure: Payer partnership agreements that can be used during product launches
Figure: Medical activities plan for a new product launch: external education activities
Figure: The KOL engagement model
Figure: The publication planning process
Figure: Percentage of US physicians intending to increase their prescribing as a result of specific promotional activity
Figure: An example market access plan for the launch of a new drug
Figure: An example market research plan for the launch of a new drug